Nevertheless, reading the EU’s positions on the pharmaceutical and medical devices (e.g. pace makers, hip implants) chapters of TTIP, a health-savvy reader cannot help but conclude that a number of issues would be better off addressed in bilateral technical fora rather than in the context of a politically-charged trade agreement, such as TTIP.
We have analysed these issues in our position paper Health and TTIP.
In this blog post, I would like to take a look at those areas which could better serve consumers if tackled within TTIP, as well as at those which European consumers would rather see excluded from the transatlantic negotiations.
Health issues better addressed within TTIP
- Harmonised requirements for the authorisation of medicines
There are currently some differences in the way in which clinical trials are conducted, especially those involving children, making it difficult to compare data and mutually accept studies. If both the EU and the US adopted similar technical requirements to show medicines are safe, effective and of high quality, then the same clinical trial data could be used on both sides of the Atlantic. Adopting similar high standards across both regions would save resources and spare more patients from the risky process of experimenting with medicines. Additionally, we support the convergence of authorisation systems for paediatric medicines, biosimilars and generics.
- Mutual recognition of inspections
Currently, European and American authorities inspect companies’ facilities on their territories and in third countries to check compliance with ‘good manufacturing practices’ (GMP) and verify the quality of products. Closer cooperation between the EU and the US could avoid duplicating inspections, resulting in using resources more effectively.
- Medical devices
The main areas for possible cooperation in the medical devices sector as outlined in the EU position on medical devices in TTIP (e.g. convergence of systems for tracking devices) would be beneficial for consumers. The EU would also benefit from adopting American safety standards on medical devices. European consumers are often treated as ‘guinea pigs’ in comparison to those in the US, where a pre-market approval system allows for closer scrutiny of the safety and effectiveness of products such as pacemakers and breast implants before they are available on the market. Regrettably this is not the case in the EU. That’s why it is a missed opportunity to exclude a harmonised approval system with American standards for devices from the talks.
Health issues better addressed outside TTIP
- Drug pricing and reimbursement
EU governments should retain full autonomy to make pricing and reimbursement decisions about pharmaceuticals and medical devices in the public interest. Transparency about how drug prices are set and how reimbursement decisions are made is crucial for consumers.
We should not forget that corporate pressure has played an influential role in past decisions to reimburse the cost of medicines that are of unproven or limited efficacy. This has been to the cost of consumers and EU health systems.
- Clinical trials
The newly adopted European Regulation on clinical trials (n. 536/2014) and the new European Medicines Agency (EMA) policy on publication and access to clinical trials data have put Europe at the forefront in terms of regulatory transparency and accountability. As a result, Europeans will benefit from greater access to information regarding the safety and efficacy of their medicines. Consumers should not have to give up this right in the name of trade.
- Extension of intellectual property protection
The EU has already granted 20 years of patent protection and a number of other exclusivities to certain medicinal products. In general, longer patent protection and exclusivity delay competition from generics and keep medicine prices high, with the healthcare system and, ultimately, the consumer paying the cost.
TTIP should not lead to any extension of the intellectual property rights and exclusivities already applied in the EU.
- Health services
Consumers throughout Europe have been concerned that their health care systems will be impacted by TTIP, with the most prominent example that of the National Health Service in the UK. We call for a complete exclusion or a “carve out” of health services from the scope of application of TTIP.
Regulatory cooperation on health: old news
TTIP has been promoted as the trade agreement which will introduce regulatory cooperation in a wide range of fields.
Nevertheless, it is noteworthy that in many aspects of pharmaceutical regulation and investment, the EU and the USA are already engaged in global or bilateral cooperation.
At the end of the day, TTIP negotiators’ success will be measured by their choice of appropriate fora for making decisions about health regulation for Europe. It’s time decisions were made in patients’ interests.
 A medical device is a product used to prevent, diagnose, or cure a disease or condition. Whereas a pharmaceutical operates chemically within the body, a medical device has a mechanical function. Such devices are classified under different risk categories. Low-risk devices include contact lenses and plasters. Pacemakers and hip implants belong to the high-risk group. The size of a medical device can also vary considerably, from a syringe needle to a mounted X-ray machine.
 Biosimilars are biological medicines similar to other biological medicines that have already been authorised for use. Biological medicines are medicines that are made by or derived from a biological source, such as a bacterium or yeast. A biosimilar can be manufactured when the original product’s patent expires.
 Generics are medicines that are developed to be the same as medicines that have already been authorised, called the ”reference medicines”. A generic medicine contains the same active substances as the reference medicine, and it is used at the same doses to treat the same diseases. Generic medicines are manufactured according to the same quality standards as all other medicines. A company can only develop a generic medicine only after the patent of the reference medicine has expired.
Note: Katrina Perehudoff, Health Policy Officer; Ilaria Passarani, Head of the Food & Health Department and Elisavet Sergiadou, communications officer contributed to the drafting of this blog post.